Cardiologists are experts in the diagnosis and treatment of heart rhythm disorders, such as tachycardia (excessively fast and abnormal heart rates) and bradycardia (excessively slow and abnormal heart rates). Disorders of the heart's electrical system are the primary cause of heart rhythm disorders, which, in turn, cause ineffective pumping of the blood, thereby placing a patient at risk of loss of consciousness and sudden death. Under managed care, access to medical specialists, such as cardiologists and cardiac electrophysiologists (cardiologists who focus purely on the heart's electrical system), requires a patient's primary care provider to first make a referral. Primary care physicians typically undertake their own diagnostic testing and screening before referring a patient. Evaluating the patient thoroughly often involves the ordering of tests. Each step preceding cardiac specialist referral, though, adds on an additional 30 percent of administrative overhead costs on average, while a failure by a primary care provider to act may force patients to seek assistance through the emergency room, thereby increasing emergency services' already overwhelming burden.
The diagnosis of cardiac rhythm disorders is challenging to address in the brief period of in-clinic exposure to the primary care provider due to the intermittent and variable nature of most heart rhythm disorders. Moreover, a patient's symptoms, such as syncope, presyncope, palpitations, angina, dyspnea, and fatigue, are consistent with many health problems, other than heart rhythm disorders, including benign causes. The ability of a primary care provider to make the appropriate diagnosis can be extremely challenging and the tools to aid in this diagnosis difficult to access. Moreover, an overall decline in the skills required to diagnose and treat heart rhythm disease in the general medical community has made primary care providers ill-equipped to make the kinds of classic arrhythmia diagnoses required to prevent or treat a serious illness. Furthermore, primary care providers are artificially limited in their ability to make patient referrals to cardiac specialists due to managed care restrictions, third-party provider rules, and practical obstacles in accessing needed diagnostic tools that are usually not in the same physical location as the primary care provider.
Current forms of diagnostic testing available in-clinic to primary care providers, typically only the standard 12-lead electrocardiogram (ECG), are inadequate to identify cardiac rhythm disorders in the context of today's limitations in time, finances, and obstacles in the patient referral network. For instance, the conventional 12-lead ECG test is merely a “snapshot” of a patient's heart rhythm, lasting approximately 10 seconds. While 12-lead ECG testing can identify many forms of persistently-presented heart disease, 12-lead ECG testing is of nominal assistance in identifying episodic heart rhythm disorders that rarely are present during clinic visits.
Other forms of ECG testing are more effective at identifying cardiac rhythm disorders but are seldom ordered by primary care providers because of the administrative and cost hurdles incurred in attempting the use of such tools. For instance, U.S. Pat. No. 3,215,136 issued Nov. 2, 1965 to Holter et al. discloses an electrocardiographic recording and playback means, more commonly known as a “Holier monitor” named after its inventor, Norman Holter in 1949. Holter monitor is now used synonymously with long-term heart rhythm recording, usually lasting at least 24 hours. With use of a Holter monitor, episodes of ventricular tachycardia, asystolic intervals, and ectopic heart beats are sensed and recorded by electrodes placed on the patient's skin. ECG rhythm disturbances recorded by the Holter monitor can then be identified. In less constrained times, such abnormalities would be seen by cardiologists, who have been contracted to overread the Holter recordings and provide diagnostic information to the referring primary care provider. These cardiologists would, in turn, care for the patient should a serious rhythm disorder be identified. Times have changed, however, and this older model of health care is no longer easily used or, if used, taken to the next step of referral and care by a cardiac specialist because of logistical and cost constraints.
The value of ambulatory ECG or Holter monitoring and the appropriate use of this technology, especially by primary care providers, suffers from several drawbacks. First, under managed care, ambulatory ECG monitoring is usually physically inaccessible to primary care providers in their offices. Such monitoring requires a referral to a testing laboratory, plus an additional referral to a cardiologist to interpret any findings, presuming the results of the Holter recording actually make their way back to the referring primary care provider, which is not necessarily a guaranteed event. Further obstacles arise by virtue of the need for the patient to be compliant with accessing, properly using, and returning the monitor to the pickup location, as well as communication burdens that arise between the referring physician, the overseeing cardiologist, and feedback to the patient following the outcome of the test. This communication complexity often leads to patients either not receiving the diagnostic equipment, not having the test results communicated to them, or not having an appropriate follow up with a knowledgeable physician. Too commonly, no one calls the patient post-monitoring. In essence, the patient is left outside the health care channel and must wait until, and if, he is informed of test results and follow up care. In addition, the reading of recorded ECG data usually requires an analysis by a heart disease specialist, which incurs additional cost and loss of time in making the patient diagnosis. Such back-end burdens can dissuade or even prevent a primary healthcare physician from ordering ambulatory ECG monitoring in the first place.
U.S. Patent application, Publication No. 2007/0255153, filed Nov. 1, 2007, to Kumar et al.; U.S. Patent application, Publication No. 2007/0225611, filed Feb. 6, 2007, to Kumar et al.; and U.S. Patent application, Publication No. 2007/0249946, filed Feb. 6, 2007, to Kumar et al. disclose a non-invasive cardiac monitor and methods of using continuously recorded cardiac data. A heart monitor suitable for use in primary care includes a self-contained and sealed housing. Continuously recorded cardiac monitoring is provided through a sequence of simple detect-store-offload operations that are performed by a state machine. The housing is adapted to remain affixed to a mammal from at least seven days up through four weeks. The heart monitor can include an activation or event notation button, the actuation of which increases the fidelity of the ECG information stored in the memory. The monitor is specifically intended to provide monitoring continuously and without interruption over an extended period, after which the stored information can be retrieved and analyzed offline to identify ECG events, including determining the presence of an arrhythmia.
Finally, U.S. Patent application, Publication No. 2008/0284599, filed Apr. 28, 2006, to Zdeblick et al. and U.S. Patent application, Publication No. 2008/0306359, filed Dec. 11, 2008, to Zdeblick et al., disclose a pharma-informatics system for detecting the actual physical delivery of a pharmaceutical agent into a body. An integrated circuit is surrounded by pharmacologically active or inert materials to form a pill, which dissolve in the stomach through a combination of mechanical action and stomach fluids. As the pill dissolves, areas of the integrated circuit become exposed and power is supplied to the circuit, which begins to operate and transmit a signal that may indicate the type, A signal detection receiver can be positioned as an external device worn outside the body with one or more electrodes attached to the skin at different locations. The receiver can include the capability to provide both pharmaceutical ingestion reporting and psychological sensing in a form that can be transmitted to a remote location, such as a clinician or central monitoring agency.
Therefore, a need remains for a way to provide primary care providers with direct on-hand access to ambulatory ECG monitoring without adding significant procedural obstacles, cost or time burdens, and which work within the confines of managed care, while simultaneously providing important diagnostic information and appropriate care directly to the patient through a closed health care loop.